Immunology

This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

The diagnostics company is working in harmony with government-led efforts to reduce transmissions of HIV in the UK.

The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.

OrganOx will use the new money to scale up their commercial presence and further validate the efficacy of their Metra system.

The White House Office of Science and Technology Policy has released an updated national strategic framework outlining priorities and goals for federal investment in AI. Industry executive Peter Shen weighs in on the plan.

The US agency warns that autoinjector devices used to inject prescription multiple sclerosis drugs may only be compatible with certain drugs and not others.

The US House of Representatives overwhelmingly passed legislation authorizing the creation of a federal health agency to advance biomedical research. The bill now goes to the Senate.

Digital female-centric primary and preventive care and fertility support were top-funded women’s health segments in 2021, drawing $668m and $330m in investments, respectively. Going forward, experts anticipate innovation to address unmet needs related to menopause, vaginal microbiome, endometriosis, and other chronic conditions, and surgeries such as hysterectomies and mastectomies.

Vitamin D3 stimulates immune system and raises nutrient's level in body more than vitamin D2, study finds. Study also recommend further research to investigate different physiological roles for D2 and D3.

The mixture in some faulty Abbott PCR tests could cause COVID-19 positive samples to flow into neighboring negative samples, resulting in false-positive results.

Now that Pfizer’s COVID-19 vaccine has been approved by the US FDA, the president said there’s no reason why private companies cannot mandate vaccination of their employees.

The US House Committee on Energy and Commerce advanced multiple bipartisan bills focused on immunization, cybersecurity, addiction, and other health issues.

The deal is Veracyte’s second major acquisition in cancer diagnostics in 2021 after agreeing to acquire Decipher Biosciences in March.

Deal-making and financing activities are on the rise for liquid biopsy diagnostic products in 2021 despite questions remaining around whether the technology can unseat standard-of-care biomarker and imaging tests.

Deal-making and financing activities are on the rise for liquid biopsy diagnostic products in 2021 despite questions remaining around whether the technology can unseat standard-of-care biomarker and imaging tests.

Myriad has sold several business units as it narrows its focus to oncology, women's health and mental health diagnostics. CEO Paul Diaz says the moves will allow the company to be a market leader.

Labcorp has agreed to pay $150m in cash for Myriad Genetics’ autoimmune business, one of three major units Myriad is unloading as it tries to narrow its focus to oncology, women's health and mental health diagnostics.

The randomized trial will evaluate SetPoint's bioelectronic platform in patients with moderate-to-severe rheumatoid arthritis, supported by funds secured in a recent preferred stock financing.

The House Ways and Means Committee wants to stop the coronavirus and work on trade issues in 2021, say the panel’s leaders.